Phase III study with avatrombopag in CIT misses goals

9 October 2020
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Disappointing top-line results from the Phase III study with avatrombopag, an oral thrombopoietin receptor agonist (TPO), in cancer patients with solid tumors and cytostatics-induced thrombocytopenia (CIT), sent Swedish Orphan Biovitrum’s (STO: SOBI), also known as Sobi, shares plunging 19% to 180.70 Swedish kronor by late afternoon.

Although avatrombopag (trade name Doptelet), as expected, increased platelet counts relative to placebo, the study did not meet the combined primary endpoint for avoiding platelet transfusion, a dose reduction of 15% or more by chemotherapy, and a four-day delay in chemotherapy. or more. In the intent-to-treat population (complete analysis), 69.5% and 72.5%, respectively, of avatrombopag patients and placebo patients were considered to respond to the primary endpoint (p = 0.72). In the per-protocol population, 85.0% and 84.4%, respectively, of avatrombopag patients and placebo patients were considered to respond to the primary endpoint (p = 0.96).

Further data analyses underway

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